INDICATIONS, SAFETY, AND WARNINGS Mo.Ma Ultra Proximal Cerebral Protection Device

Note: Safety information provided is for the United States.  Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at (877) 526-7890. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. 


REFERENCE STATEMENT

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions.

Indications for Use: The Mo.Ma™ Ultra proximal cerebral protection device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and/or the carotid bifurcation.

The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-16 Rev. 1A